This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for V501 Immunogenicity Study in Females Age 9 to 17 Years (V501-028) (NCT00411749), a randomized phase 2 study. The primary outcome is Human Papilloma Virus (HPV) 6 Serum Antibody Titer at One Month After Completed Vaccination Series.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00411749 |
| Phase | Phase 2 |
| Condition | HPV Infections |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 107 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Merck Sharp & Dohme LLC |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned females aged 9 to 17 years, with HPV infections listed as the condition. The primary immunogenicity analysis used a per protocol population: participants had to avoid general protocol violations, receive all 3 vaccinations within acceptable day ranges, be seronegative at Day 1 for the relevant HPV type, and have a Month 7 serum sample collected within an acceptable time range. The registry reports 107 enrolled overall; the primary endpoint groups include 80.0 participants for V501 and 25.0 for placebo.
Intervention
The intervention was V501, a quadrivalent recombinant HPV vaccine covering types 6, 11, 16 and 18. The arm description specifies 3 vaccinations, with a 0.5 mL intramuscular dose, on Day 1, Month 2 and Month 6. The study brief describes its purpose as evaluating immunogenicity, safety and tolerability in preadolescent females.
Comparator
The comparator was placebo, described as a 0.5 mL injection in a 3-dose regimen. The registry identifies the study as randomized, double masked and parallel group. Further details of how randomization and masking were implemented are not reported in the registry record.
Primary question
The primary endpoint asked whether the groups differed in HPV 6 serum antibody titer at one month after the completed vaccination series, at Month 7. Titers were measured with a competitive Luminex immunoassay and summarized as geometric mean titers. The registry reports a Wilcoxon (Mann-Whitney) comparison with p < 0.001. This is an immunogenicity comparison; it is not a direct comparison of HPV infection, disease, or clinical outcomes.
3. Trial Design
The registry identifies this as V501-028, a Phase II study of immunogenicity in females aged 9 to 17 years. Its design is listed as randomized, double masked and parallel group, with V501 vaccination compared with placebo. The overall enrollment was 107. The sponsor was Merck Sharp & Dohme LLC. The registry lists HPV infections as the condition and describes the study as evaluating immunogenicity, safety and tolerability.
The V501 arm description specifies a quadrivalent vaccine containing HPV types 6, 11, 16 and 18, delivered as a 0.5 mL intramuscular dose in 3 vaccinations at Day 1, Month 2 and Month 6. The placebo arm is described as a 0.5 mL injection in a 3-dose regimen. The registry does not give further operational details about sequence generation, allocation concealment, masking procedures, or whether masking applied to particular roles.
The primary endpoint was HPV 6 serum antibody titer at Month 7, one month after completion of the vaccination series. The primary analysis population was per protocol, with eligibility defined by protocol adherence, vaccination timing, seronegativity at Day 1 for the relevant HPV type, and a serum sample within the acceptable Month 7 time range. The endpoint groups contain 80.0 V501 participants and 25.0 placebo participants. The registry does not report a full participant-flow account explaining how these analysis counts relate to overall enrollment.
The study began on 2006-12-11, reached primary completion on 2009-09-18 and is listed as completed. One secondary outcome is described: HPV 6, 11, 16 and 18 serum antibody titers at 24 months after the completed vaccination series. The registry record does not provide further protocol details on the planned analyses or the handling of all collected outcomes.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | V501 | Placebo |
|---|---|---|
| STARTED | 82 | 25 |
| Vaccinated | 82 | 25 |
| COMPLETED | 82 | 25 |
| NOT COMPLETED | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: The per protocol immunogenicity population includes all subjects who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and a Month 7 serum sample collected within an acceptable time range.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | V501 | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 82 | 25 | 107 | |
| Age, Continuous | years | 12.8 (SD 2.4) | 12.6 (SD 2.6) | 12.7 (SD 2.4) |
| Sex: Female, Male: Female | Participants | 82 | 25 | 107 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Body Weight | Kilogram | 45.5 (SD 10.8) | 45.2 (SD 9.6) | 45.4 (SD 10.5) |
6. Primary Endpoint
The registry lists the primary outcome as Human Papilloma Virus (HPV) 6 Serum Antibody Titer at One Month After Completed Vaccination Series, measured over At one month after completed vaccination series (Month 7).
| Element | Registry entry |
|---|---|
| Result type | Geometric Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | Geometric Mean Titers (mMU/mL) |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the HPV 6 serum antibody titer measured at one month after the completed vaccination series, identified as Month 7. The assay was a competitive Luminex immunoassay. Results are expressed as geometric mean titers in mMU/mL, with 95% confidence intervals. A geometric mean summarizes measurements on a multiplicative scale: conceptually, values are transformed to a logarithmic scale for averaging and then expressed back on the original scale. This is generally useful for antibody measurements that can vary widely and are not well represented by an ordinary arithmetic average.
Antibody titers are an immunogenicity measure: they describe the antibody response detected by the assay. They are not themselves measurements of infection, disease, or another clinical outcome. The registry record states that the assay limit of detection was 7 mMU/mL. GMTs and confidence limits below that limit are displayed as 7.0. This means the reported value at the assay floor should be read in light of the detection limit; the record does not establish an exact measurable titer below that threshold.
The selected time point captures the response one month after the final scheduled vaccination, rather than a response at a later follow-up. The registry also lists a secondary antibody outcome at 24 months, but the primary result concerns HPV 6 at Month 7. Why this endpoint was selected, and how it was related to any clinical outcome of interest, are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
At Month 7, the reported HPV 6 geometric mean titer was 674.5 mMU/mL in the V501 group, with a 95% confidence interval from 528.6 to 860.8. In the placebo group, the reported geometric mean titer was 7.0 mMU/mL, with a 95% confidence interval from 7.0 to 8.4. The lower bound for the placebo interval is at the assay’s stated detection limit, and the registry says that results below the limit are displayed as 7.0. The displayed placebo estimate therefore needs to be interpreted with that measurement floor in mind.
The registry reports a Wilcoxon (Mann-Whitney) comparison between the groups, with p < 0.001. This test result is evidence that the observed distributions differed under the assumptions of the test; it is not a probability that the null hypothesis is true, nor does it state the size of the difference. The geometric mean estimates and their confidence intervals describe the magnitude and precision of the group summaries, while the reported test addresses a rank-based comparison. Those summaries and the test are related but do not answer exactly the same statistical question.
The interval around the V501 estimate describes uncertainty in the estimated geometric mean, conditional on the analysis and its assumptions. It is not a range containing every participant’s antibody titer. The placebo interval is close to the detection floor, so its displayed bounds do not reveal the distribution of values that may have fallen below assay detection. The record does not provide participant-level measurements or a distributional summary beyond the posted GMTs and confidence intervals.
The analysis population is per protocol, rather than all enrolled participants. The record describes criteria for inclusion in that population, but does not give a complete accounting of exclusions or missing Month 7 samples. The observed comparison consequently pertains to the specified per protocol analysis group. It should not be treated as a direct estimate of a clinical outcome or as a result for every enrolled participant.
Overall, the posted results show a higher reported HPV 6 GMT in the V501 group than in the placebo group at the stated time point, alongside the reported rank-based test result. They do not establish how the antibody measurements relate to subsequent infection or disease, and they do not provide results for the other HPV types in the primary endpoint. Those limits follow from the outcome and analysis information reported in the registry.
9. Statistical Methods Explained
The endpoint is summarized with geometric mean titers (GMTs), and the registry gives 95% confidence intervals for each group. In general, a geometric mean is calculated using a logarithmic transformation: measurements are averaged on the transformed scale, then converted back to the original measurement scale. This approach can be useful for antibody titers because it describes a central value on a multiplicative scale. The registry reports the GMTs and intervals, but does not report the detailed computation method or any adjustment beyond the stated per protocol population.
What does a confidence interval describe?
In general, a confidence interval expresses uncertainty about an estimated quantity under a statistical method and its assumptions. The 95% intervals reported for the GMTs describe uncertainty in the estimated group summaries; they are not ranges of individual participant values. The V501 GMT is 674.5 mMU/mL, with a 95% confidence interval of 528.6 to 860.8. The placebo GMT is 7.0 mMU/mL, with a 95% confidence interval of 7.0 to 8.4. These intervals should be read alongside the endpoint’s assay limit: the registry states that the detection limit was 7 mMU/mL and that GMTs and confidence limits below it are shown as 7.0. A value at that floor is therefore not evidence that the underlying measurement was exactly 7.0.
What does the reported group comparison test?
The registry reports a Wilcoxon (Mann-Whitney) test, with p < 0.001. In general, this is a rank-based method for comparing two groups. It uses the ordering of observations rather than directly testing a difference between geometric means. Its interpretation depends on the observed distributions and the test’s assumptions. A small p-value indicates that data at least as inconsistent with the test’s null hypothesis would be unusual under that null model; it does not quantify the size of the group difference or the probability that the null is true.
The GMTs and the Wilcoxon result thus serve complementary purposes. The GMTs give a group-level summary in the endpoint’s stated units, while the Wilcoxon test supplies the reported inferential comparison. The record does not give a test statistic, a confidence interval for a between-group contrast, or further details of the test implementation. No separate recalculated comparison estimate is reported in the registry record.
How does the assay limit affect interpretation?
The assay limit of detection is a measurement boundary, not a biological threshold. General statistical handling of values below a detection limit can affect estimates and uncertainty, particularly when many measurements are near that boundary. In this record, the stated reporting convention sets GMTs and confidence limits below the limit to 7.0. The placebo group’s reported GMT is 7.0 and its lower confidence limit is also 7.0. The record does not report how many individual values were below detection, or whether any other procedure was used to handle such values before calculating the summary.
More generally, over-dispersion means that observed variability is greater than a particular statistical model anticipates. If over-dispersion is present, standard errors and confidence intervals from that model may be too narrow unless the method accounts for it. The registry does not report an over-dispersion assessment, and the rank-based method listed for the comparison is not described as a model-based analysis. This general concept does not establish that over-dispersion occurred in this study.
What does the analysis population mean?
The primary endpoint population is described as per protocol immunogenicity. Participants had to have no general protocol violations, receive all 3 vaccinations within acceptable day ranges, be seronegative at Day 1 for the HPV type being assessed, and provide a Month 7 serum sample within an acceptable time range. In general, restricting an analysis this way focuses on participants meeting prespecified conditions for evaluating an immunogenicity endpoint. It can also mean the analysis does not include everyone enrolled or randomized. The registry does not provide the number excluded for each criterion or a full account of missing samples.
The reported endpoint groups contain 80.0 V501 participants and 25.0 placebo participants. These are analysis-group counts, not a substitute for the overall enrollment figure of 107. The registry does not report the original randomized group counts or enough participant-flow detail to explain the relationship between those counts and the endpoint population.
What can the p-value and interval not answer?
In general, a p-value does not measure clinical importance, and a confidence interval does not remove uncertainty about the analysis population, measurement process, or study design. Neither statistic establishes that an antibody response predicts a clinical outcome. The endpoint is an assay-based antibody titer at Month 7, and the registry does not report a clinical outcome comparison in the primary result. Interpretation should therefore stay with the measured antibody endpoint, its assay limit, the per protocol population and the stated statistical comparison.
10. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| Wilcoxon (Mann-Whitney) | not reported | < 0.001 |
The registry reports the sponsor’s group comparison as a Wilcoxon (Mann-Whitney) test, with p < 0.001. The reported test accompanies the Month 7 HPV 6 GMT summaries: 674.5 mMU/mL for V501 and 7.0 mMU/mL for placebo. It tests a rank-based comparison between groups; it is not a reported test specifically of the difference between those two GMT estimates.
No separate recalculated test result or recalculated between-group estimate is reported in the registry record. The posted analysis is therefore the available inferential result for this endpoint. The record does not give a test statistic or further details that would allow the reported p-value to be reproduced from group-level summaries alone. The GMT confidence intervals describe uncertainty around each group summary, not a confidence interval for the between-group contrast.
The record does not flag a discrepancy between a sponsor analysis and a recalculation. The available result should be read as the sponsor-reported Wilcoxon comparison, alongside the endpoint summaries and the assay limit of detection. It supports a statistical comparison of the observed antibody measurements in the stated per protocol population; it does not by itself establish the clinical meaning of those measurements.
11. Multiplicity, Missing Data and Analysis Populations
The registry lists 5 outcome measures and 8 analyses, and identifies 1 secondary outcome as posted. The listed secondary outcome is HPV 6, 11, 16 and 18 serum antibody titer at 24 months after the completed vaccination series. The primary endpoint is HPV 6 serum antibody titer at Month 7. The record does not explain how the listed outcomes and analyses were organized into a testing strategy.
Multiplicity arises in general when several outcomes, time points, groups, or statistical tests are considered. Repeated testing can increase the chance of observing a small p-value by chance if no adjustment or prespecified hierarchy is used. The registry record does not report whether multiplicity was addressed, whether an adjustment was planned, or whether the primary endpoint was tested within a hierarchy. It would therefore be inappropriate to assume either that an adjustment was made or that none was needed under the study’s original plan.
The record defines the per protocol immunogenicity population using protocol adherence, vaccination timing, baseline seronegativity for the relevant HPV type, and a serum sample within the acceptable Month 7 window. It reports 80.0 V501 participants and 25.0 placebo participants in the primary endpoint analysis. A full account of randomized counts, exclusions by reason, missing endpoint measurements, and participant disposition is not reported in the registry record.
In general, missing outcomes can affect an analysis when their occurrence is related to participant characteristics or outcomes. The registry does not describe imputation, sensitivity analyses, or other missing-data methods for this endpoint. Nor does it report whether the per protocol criteria were set before examining results. These omissions limit assessment of how robust the result is to missing measurements or analysis-population choices.
The listed analysis population is not described as an intention-to-treat population. This is a description of the record, not a judgment about the appropriateness of the analysis. Without the full analysis plan and participant flow, the extent to which the per protocol result might differ from an analysis of all randomized participants is not reported in the registry record.
12. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| V501 | 2 | 82 | 2.4% |
| Placebo | 0 | 25 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 2% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| V501 | 77 of 82 |
| Placebo | 23 of 25 |
Most frequent serious adverse event terms
| Event term | Organ system | V501 | Placebo |
|---|---|---|---|
| Strabismus congenital | Congenital, familial and genetic disorders | 1 of 82 | 0 of 25 |
| Bronchitis | Infections and infestations | 1 of 82 | 0 of 25 |
Most frequent non-serious adverse event terms
| Event term | Organ system | V501 | Placebo |
|---|---|---|---|
| Injection site pain | General disorders | 69 of 82 | 19 of 25 |
| Injection site swelling | General disorders | 38 of 82 | 4 of 25 |
| Injection site erythema | General disorders | 35 of 82 | 5 of 25 |
| Nasopharyngitis | Infections and infestations | 9 of 82 | 5 of 25 |
| Injection site pruritus | General disorders | 12 of 82 | 1 of 25 |
| Headache | Nervous system disorders | 9 of 82 | 1 of 25 |
| Abdominal pain | Gastrointestinal disorders | 6 of 82 | 2 of 25 |
| Protein urine present | Investigations | 4 of 82 | 2 of 25 |
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | 4 of 82 | 2 of 25 |
| Pyrexia | General disorders | 4 of 82 | 1 of 25 |
Serious events with the highest arm-level rate: strabismus congenital (1.2%), bronchitis (1.2%).
The registry lists serious adverse events for V501 among 82 participants at risk, with 2 affected, and for placebo among 25 participants at risk, with 0 affected. These are the posted group counts; no additional comparison statistic or confidence interval for serious adverse events is reported in the registry record. The safety denominators differ from the primary immunogenicity analysis counts, which are 80.0 and 25.0, respectively. The record does not provide a participant-flow explanation for that difference.
The registry lists Strabismus congenital and Bronchitis among the top serious-event terms, each at 1.2%. It does not identify which treatment group is associated with each term in the information recorded here, so the terms should not be assigned to either arm. Death counts are not reported in the registry record.
Other adverse events are listed for 77 of 82 participants at risk in the V501 group and 23 of 25 in the placebo group. The registry does not provide further detail in this record about event definitions, severity, timing, or attribution. General statistical interpretation of safety counts must account for the number of participants observed and the limited precision possible when event counts are sparse. These figures describe reported events in this study; they do not establish causation or provide a complete safety assessment.
13. What the Result Does, and Does Not, Mean
The primary result concerns HPV 6 serum antibody titers measured one month after the completed vaccination series. The registry reports a GMT of 674.5 mMU/mL for V501 and 7.0 mMU/mL for placebo, with the stated confidence intervals, and a Wilcoxon (Mann-Whitney) comparison of p < 0.001. Taken together, these results describe a difference in the measured antibody response between the per protocol groups at Month 7. The placebo estimate is at the assay’s stated limit of detection, which constrains how literally its displayed value can be interpreted.
The result does not, on its own, show whether participants experienced fewer HPV infections or disease outcomes. The primary endpoint is an antibody measurement, not a direct clinical outcome. The registry record does not report that this titer predicts a particular level of protection, and no such relationship should be inferred from the statistical comparison alone. The result also does not answer how antibody levels changed over time after Month 7.
The study lists a secondary antibody outcome for HPV types 6, 11, 16 and 18 at 24 months, but the primary result is limited to HPV 6 at Month 7. The record does not provide a posted result for that secondary outcome in the information available. Results for other HPV types, or for other outcome measures, cannot be inferred from the HPV 6 primary endpoint.
The analysis applies to the stated per protocol immunogenicity population, not necessarily every enrolled participant. The criteria require protocol adherence, timely receipt of all 3 vaccinations, baseline seronegativity for the relevant type, and an acceptable Month 7 sample. The registry does not report the full participant flow or missing-data handling, which limits assessment of how these choices affect the result.
Finally, the reported p-value is evidence from a statistical test, not a measure of clinical importance. The GMT estimates and confidence intervals communicate the scale and uncertainty of the antibody summaries, but neither resolves questions outside the measured endpoint. The findings should be understood as a statistical description of the registry’s Month 7 immunogenicity comparison.
14. Why This Trial Matters Statistically
This study is statistically notable because it combines an immunogenicity endpoint with an assay whose stated detection limit is close to the placebo group’s reported GMT. The registry reports the placebo GMT as 7.0 mMU/mL and says values below the 7 mMU/mL limit are displayed as 7.0. That reporting convention matters: a summary at the assay floor is not equivalent to a precisely measured value at that level, and the floor can influence how the endpoint is interpreted.
The result also illustrates that an endpoint summary and a hypothesis test can answer different questions. GMTs describe group-level antibody summaries on a geometric scale, while the reported Wilcoxon (Mann-Whitney) test is rank-based. A p-value from that test is not a direct measure of the magnitude of the GMT contrast. Reading the summaries, intervals, assay characteristics and test together gives a more complete statistical interpretation than treating the p-value as the entire result.
The per protocol population is another important feature. Its criteria connect eligibility to protocol adherence, vaccination timing, baseline seronegativity and availability of a Month 7 sample. The registry reports analysis counts but not a full participant flow. Readers therefore need to distinguish the overall enrollment of 107 from the endpoint population and recognize that the posted result pertains to the defined analysis group.
More broadly, the record demonstrates why immunogenicity results should be kept distinct from clinical outcomes. The measured quantity is an antibody titer at a specified time, not infection or disease. Statistical precision for that laboratory endpoint does not answer questions the endpoint was not designed to measure. The registry does not report a clinical outcome comparison or the details needed to connect these titers to one.
15. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The primary result is limited to HPV 6 antibody titers at Month 7. Although the registry lists a secondary outcome for HPV types 6, 11, 16 and 18 at 24 months, that later result is not reported in the registry record. The primary result does not describe the other HPV types or the durability of the antibody response.
The assay’s detection limit was 7 mMU/mL, and results below the limit were displayed as 7.0. The placebo GMT and its lower confidence limit are both at that reporting floor. The registry does not state how many individual measurements were below detection or describe any additional method for handling them. This limits interpretation of the placebo summary and its interval.
The per protocol immunogenicity population excludes participants who did not meet the stated adherence, timing, baseline-seronegativity and sample-window criteria. Although the endpoint group counts are reported, the registry does not give a complete flow from enrollment through analysis, exclusion counts by reason, or details of missing-data handling. The original randomized group counts are not reported in the registry record.
The statistical report gives a Wilcoxon (Mann-Whitney) test and p < 0.001, but does not report a test statistic or a confidence interval for a between-group contrast. It also does not report the full analysis plan, how multiplicity was handled, or the methods used for other outcomes. The record lists 5 outcome measures and 8 analyses, but does not explain their relationship to a prespecified testing strategy.
Safety information is also limited in the record. Serious adverse-event counts are listed, but no deaths count is reported, and the two serious-event terms with percentages are not assigned to a treatment group. Details such as timing, attribution and event definitions are not reported in the registry record. These limitations do not negate the reported antibody comparison, but they constrain what can be concluded beyond that endpoint and analysis population.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: V501 Immunogenicity Study in Females Age 9 to 17 Years (V501-028) — NCT00411749.
- Registry record last updated 2017-04-21; status last verified 2017-03.
- Results first posted 2010-08-18.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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19. Record Summary
NCT00411749 is a completed, randomized, double-masked, parallel-group Phase II study titled V501 Immunogenicity Study in Females Age 9 to 17 Years (V501-028). The sponsor is Merck Sharp & Dohme LLC, and HPV infections are listed as the condition. The study enrolled 107 participants and began on 2006-12-11, with primary completion on 2009-09-18.
The intervention was quadrivalent V501 vaccine for HPV types 6, 11, 16 and 18; the comparator was placebo. The primary endpoint was HPV 6 serum antibody titer at Month 7, measured by competitive Luminex immunoassay and summarized as a geometric mean titer with a 95% confidence interval. The reported GMTs were 674.5 mMU/mL for V501 and 7.0 mMU/mL for placebo, with a Wilcoxon (Mann-Whitney) result of p < 0.001. The assay limit of detection was 7 mMU/mL, and results below it were displayed as 7.0.
The primary endpoint analysis used the per protocol immunogenicity population. The registry also lists a 24-month antibody outcome for HPV types 6, 11, 16 and 18. Further protocol, multiplicity, missing-data and participant-flow details are not reported in the registry record.